Kornimate/medical-research-clean huggingface dataset:
efficacy of extended infusion of β-lactam antibiotics for the treatment of febrile neutropenia in hematologic patients

Conditions: Febrile Neutropenia

Summary: this study evaluates the administration of beta-lactam antibiotics in extended infusion in hematological patients with febrile neutropenia after 5 days of treatment. the beta-lactam antibiotics analyzed are the following: piperacillin-tazobactam, cefepime and meropenem. half of patients will receive the antibiotic in intermittent infusion, while the other half will receive it in extended infusion.

febrile neutropenia (fn) is a very frequent complication in patients with hematological malignancies. it is associated with an important morbidity and mortality. nowadays the use of betalactam antibiotics (bla) in extended or continuous infusion (ei, ci) instead of intermittent infusion (ii), has demonstrated a therapeutic success and lower mortality rate in critically ill intensive care patients. neutropenic patients are a particular population since fn is assoicated with pathophysiological variations that compromise pharmacokinetic parameters of bla, and may therefore, diminish their clinical efficacy. information regarding the usefulness of bla in ei in neutropenic hematologic patients is scarce. the objective of this randomized clinical trial is to demonstrate the clinical superiority of the administration of bla in ei compared to ii in patients with fn.

Eligibility criteria:
inclusion criteria: 1. adult patients (age ≥18 years) of both sexes. 2. patients admitted in hematological wards. 3. with any of the following diagnoses: 1. acute leukemia receiving chemotherapy. 2. autologous or allogeneic hematopoietic stem cell transplant recipients. 4. with an episode of febrile neutropenia: ≥ 38.0ºc and \<500 neutrophils/mm3 or \<1000 with a predicted decrease within 24-48 hours. 5. patient requiring treatment with a beta-lactam antibiotic: cefepime, piperacillin /tazobactam or meropenem, in monotherapy or in combination with another antibiotic. 6. written informed consent has been obtained from the patient or their legal representative grants. exclusion criteria: 1. allergy to study drugs. 2. patient receiving systemic antibiotic treatment (except for prophylaxis) at the time of onset of febrile neutropenia. 3. absence of fever. 4. patients with epilepsy. 5. severe renal impairment (defined as creatinine clearance \<30 ml / min) 6. previously enrolled patients in whom the time between the inclusion and the current episode is less than 5 weeks. 7. previously enrolled patients without current resolution of the first episode.

Keywords: febrile neutropenia beta-lactam antibiotics cefepime meropenem piperacillin-tazobactam extended infusion
the impact of heart rate on central blood pressure in sick sinus syndrome patients with a permanent cardiac pacemaker

Conditions: Aortic Blood Pressure

Summary: this study is divided into two parts: * the first part evaluates the acute effect of non-pharmacological heart rate change on central hemodynamic parameters noninvasively in sick sinus syndrome patients with a permanent cardiac pacemaker * the second part evaluates the acute effects of atenolol, nebivolol and ivabradine on central hemodynamic parameters noninvasively in sick sinus syndrome patients with a permanent cardiac pacemaker at different pacing rate levels

patients with sick sinus syndrome and a double-chamber cardiac pacemaker are studied. * to investigate the role of non-pharmacological heart rate change on central hemodynamics in the first part of the study, the investigators acutely change pacing rate from atrial paced-atrial sensed (aai)-mode 60 to 40 to 90 bpm and obtain hemodynamic parameters noninvasively after a short stabilisation period after each pacemaker rate change. * subsequently, to investigate the acute effects of beta-blockers or ivabradine on central hemodynamics in the second part of the study, the investigators obtain central hemodynamic parameters noninvasively after acute administration of atenolol, nebivolol or ivabradine at the same pacing rate levels used in the first part of the study (aai-mode 60, 40 and 90 bpm).

Eligibility criteria:
inclusion criteria: * age 18-75 years; * dual-chamber pacemaker implanted due to sick sinus syndrome at least six months before; sinus rhythm exclusion criteria: * average seated office brachial systolic bp ≥160 mmhg and/or diastolic bp ≥ 100 mmhg; atrial pacing \<40%; * ventricular pacing \>25%; * unpaced qrs \>120 ms and/or qtc \>500 ms on 12-lead ecg; * atrioventricular blockage at aai-mode 90 bpm; resting hr \>60 bpm at aai-mode 40 bpm; irregular heart rate; * automatic mode switching \>10%; * implantable cardioverter defibrillator or cardiac resynchronisation therapy pacemaker; treatment with digoxin, class ic or iii antiarrhythmic drugs; * history of acute coronary syndrome; * stable angina pectoris; * heart failure with reduced left ventricular ejection fraction; * history of cerebrovascular event; * diabetes mellitus; * chronic kidney disease with egfr \<30 ml/min/m2; * peripheral artery disease; * clinically relevant heart valve disease; * active cancer; * acute or chronic inflammatory disease; * severe chronic respiratory or liver disease; * pregnancy or breastfeeding * contraindication or intolerance to atenolol, nebivolol, ivabradine or adjuvants

Keywords: sick sinus syndrome heart rate aortic blood pressure artificial pacemaker beta-blockers ivabradine
paracervical block for pain associated with laminaria insertion

Conditions: Pain

Summary: to assess if paracervical block is effective at reducing discomfort during placement of intracervical laminaria for pre-operative cervical preparation.

pre-operative dilation of the cervix with use of osmotic dilators (e.g. laminaria, dilapan-s) is commonly done prior to pregnancy termination to make the procedure safer. this study seeks to assess whether paracervical blocks are effective at reducing pain associated with placement of laminaria. secondarily, this study will evaluate if paracervical blocks are effective at reducing overall procedural pain and increasing overall patient satisfaction for the intracervical laminaria placement procedure.

Eligibility criteria:
inclusion criteria: * pregnant women between the ages of 18-49 years * desiring surgical termination of pregnancy or surgical management of a fetal demise * treatment plan involves cervical preparation with laminaria * participant able to provide informed consent in english and willing to participate in the study exclusion criteria: * unable to read/speak/understand english * contraindications to receiving lidocaine

Keywords: laminaria
efficacy study of a urine dek elisa for diagnosis of bladder cancer

Conditions: Hematuria; Dysuria; Bladder Cancer

Summary: the objective of this study is to use a dek elisa to quantitatively measure dek protein in the urine of patients suspected of having bladder cancer. the measurement of urine dek protein, relative to an established cut-off, is correlated with the presence or absence of bladder cancer.

sample collection: urine samples used in the study will be collected immediately prior to the urological evaluation procedure and stored at -80 oc. urine samples will be sent to sponsor and remain at -80o c until analysis. clinical data collection: all subject and clinical information will be recorded on the form in section 9.3. enrollment checklist and case report form (crf). information regarding the history of hematuria and urine cytology will be recorded. in addition, non-identifying information including age, sex, race, smoking history, alcohol consumption, occupational exposure to chemicals or dyes, history of urologic disorder or disease, history of irritative voiding symptoms, history of urinary tract infection, history of pelvic irradiation, and analgesic abuse will be recorded. the investigators will also be asked to provide information from the subjects' medical records for up to one (1) year after their enrollment and sample collection. in particular, diagnosis of tcc, other malignant diseases, or non-malignant urogenital conditions will be provided.

Eligibility criteria:
inclusion criteria: * patients who are at least twenty-five (25) years of age with hematuria, dysuria or other irritative voiding symptoms, without evidence of other causative factors such as infections or stones. exclusion criteria: * females who are pregnant (ascertained by history) * females who are menstruating or within three (3) days of their last menstruation * patients who have undergone invasive procedures of the urogenital tract in the past two (2) months * patients with a history of transitional cell carcinoma (tcc) of the urinary tract

Keywords: bladder cancer tcc urine protein elisa
digital single-operator cholangioscopy and intraductal ultrasound for nonicteric biliary strictures

Conditions: Cholangiocarcinoma; Biliary Stricture

Summary: this study aims to evaluate the usefulness of disposable digital single-operator cholangioscopy (soc) and intraductal ultrasound (idus) for the accurate diagnosis of indeterminate biliary stricture.

although early and accurate diagnosis of cholangiocarcinoma from the biliary stricture is important, accurate differential diagnosis is still difficult even in computed tomography and magnetic resonance imaging. we planned to evaluate the usefulness of disposable digital single-operator cholangioscopy (soc) and intraductal ultrasound (idus) for the accurate diagnosis of biliary stricture.

Eligibility criteria:
inclusion criteria: 1. patients aged 19 to under 80 2. presence of nonicteric biliary stricture 3. previous endoscopic sphincterotomy or papillary balloon dilatation exclusion criteria: 1. bleeding tendency (inr \&gt; 1.5 or platelets \&lt; 50000 mm3) 2. contraindication to ercp

Keywords: intraductal ultrasound digital single-operator cholangioscopy indeterminate biliary stricture
the effect of metoprolol on anaesthesia, the need for analgesics, and pain in breast cancer patients

Conditions: Breast Cancer

Summary: the purpose of the study is to test the effects of metoprolol on anaesthesia and the need for perioperative analgesics in patients undergoing breast surgery. with 12 months follow-up the incidence of pain and life satisfaction will be evaluated.

the purpose of the study is to test the effects of intraoperative metoprolol on 1) anaesthetic and alagesic use 2) pain during the early postoperative period and 3) the incidence of pain and lide satisfaction up to 12 months after the surgery. adverse effects will be recorded as safety measures.

Eligibility criteria:
inclusion criteria: * elective breast surgery due to breast cancer * voluntary * bmi ≥ 18 and ≤ 35 kg/m2 * asa 1-3 * no regular use of beta-blockers or during the last 72 hours * no contraindications to beta-blockers exclusion criteria: * pregnancy or breast feeding * av-block, degree ii or iii * untreated cardiac insufficiency * sinus bradycardia, heart rate \< 45 / min or symptoms * sick sinus syndrome * cardiogenic shock * severe peripheral vascular disorder * systolic blood pressure \< 100 mmhg * long pq-time, \> 0,24 seconds * known hypersensitivity to beta-blockers or the ingredients of the drug
evaluation of the electronic cigarette withdrawal syndrome

Conditions: E-cigarette Use; Withdrawal

Summary: the goal of this project is to rigorously evaluate the nature of e-cigarette withdrawal in exclusive e-cigarette users during a monitored abstinence period and the role of nicotine in the expression of this withdrawal syndrome.

this project will use a rigorous residential laboratory design to evaluate e-cigarette withdrawal expression and experimentally determine the role of nicotine in this syndrome. healthy adults who exclusively use e-cigarettes will undergo monitored e-cigarette abstinence over seven days (1 week) in a residential unit. the investigators will evaluate the contribution of nicotine to withdrawal expression by assigning participants to one of three conditions: active nicotine patch, placebo patch control, or no patch to control for expectancies. standardized behavioral and biological measures associated with withdrawal including patient report, cognitive task performance, and biometrics will be collected throughout to establish a rigorous timecourse of withdrawal and evaluate the contribution of nicotine to these symptoms.

Eligibility criteria:
inclusion criteria: 1. 21-55 years old 2. good general health as reviewed by study medical team 3. vital signs in normal range as reviewed by study medical team 4. negative urine test for illicit drug use (excluding thc) and negative breath alcohol test 5. daily use of a nicotine-containing e-cigarette for at least 6 months 6. no regular use of other tobacco products (e.g., smokeless products) for at least 6 months 7. urine cotinine \>100ng/ml (i.e., recommended cutoff for confirming current nicotine use) 8. exhaled breath carbon monoxide (co) \<6ppm 9. penn state e-cigarette dependence (psed) score \>=4, indicating mild dependence or greater 10. have an interest in reducing e-cigarette use exclusion criteria: 1. psychoactive drug use (aside from cannabis, nicotine, alcohol, caffeine) in past month 2. current use of over-the-counter (otc) or prescription medications that may impact safety 3. use cannabis \>2 times per week 4. history of or current significant medical condition that would impact participation or safety according to the study investigators and medical staff 5. current psychiatric condition or substance use disorder (aside from tobacco use disorder) that would impact participation or safety according to the study investigators and medical staff 6. enrollment in another trial 7. positive pregnancy test 8. currently using a nicotine/tobacco cessation product 9. seizure disorder or traumatic brain injury (tbi)
combination chemotherapy plus radiation therapy in treating patients with newly diagnosed glioblastoma multiforme

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

objectives: i. evaluate the efficacy of carmustine, cisplatin, and etoposide administered prior to and during radiotherapy in patients with newly diagnosed high grade glioblastoma multiforme. ii. assess the toxicities of this treatment regimen in this patient population. iii. assess fatigue, depression, and excessive daytime somnolence in terms of incidence, duration, and relation to age, tumor type, tumor site, cancer therapy, and symptoms in this patient population. iv. evaluate the quality of life of these patients. outline: patients receive pre-irradiation chemotherapy consisting of carmustine iv over 1 hour on days 1-3 and oral etoposide on days 1-21 and 29-49 immediately followed by cisplatin iv over 1-2 hours on days 1-3 and 29-31. treatment repeats every 8 weeks for 2 courses. patients receive concurrent cranial radiotherapy daily over 8 weeks during course 2. patients then receive carmustine iv over 1-2 hours every 8 weeks for 4 courses. treatment continues in the absence of disease progression or unacceptable toxicity. quality of life is assessed before the study, prior to each treatment course, every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. patients are followed every 4 months for 1 year, every 6 months for 4 years, annually for 5 years, and then for survival.

Eligibility criteria:
disease characteristics: histologically confirmed newly diagnosed glioblastoma multiforme no oligodendrogliomas or oligoastrocytomas patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: not specified hematopoietic: wbc at least 3,500/mm3 platelet count at least 130,000/mm3 hepatic: bilirubin no greater than 1.5 times upper limit of normal (uln) sgot no greater than 2 times uln renal: creatinine no greater than 0.5 mg/dl above uln other: no uncontrolled infection no other major medical conditions no other concurrent malignancy except superficial skin cancers must be able to read english (quality of life assessment only) no other problem that may preclude quality of life assessment not pregnant or nursing fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: concurrent steroids allowed radiotherapy: no prior radiotherapy surgery: not specified

Keywords: adult glioblastoma adult giant cell glioblastoma adult gliosarcoma
treatment of tendon disease using autologous adipose-derived mesenchymal stem cells

Conditions: Rotator Cuff Tear; Lateral Epicondylitis

Summary: this study was a single-center, randomized, single-blind clinical trial. we plan to include 100 patients who met exclusion criteria of rotator cuff and lateral epicondylosis (tennis elbow) respectively by mrt or ultrasonography. the patients will be randomly divided into two groups. adipose mesenchymal stem cells will be isolated from adipose tissue, cultured and then transplanted back to the tendon injury site by multiple point injection. 1\*10\^6 cells as an unit. patients in the experiment group will be injected into an unit of adipose mesenchymal stem cells (1\*10\^6/10kg) while the control group received the same dose compound betamethasone injection. follow up visit for all patients will occur at 1，3，6 and 12 months after the first injection. clinical quantitative assessment will measure by the visual analogue scale(vas). the secondary outcomes are the constant-murley score(cms) and the rating scale of the american shoulder and elbow surgeons(ases) and the disability of arm shoulder and hand(dash). the objective evaluation methods is that the examination of mri or ultrasound were accomplished before the first injection and at 6 and 12 months afterwards.

all injection will be done under ultrasound guidance.

Eligibility criteria:
inclusion criteria: 1. clinically diagnosed as rotator cuff tear or lateral epicondylitis (tennis elbow); 2. symptom duration is over 3 months, non-steroidal drug treatment , rehabilitation treatment and other conservative treatment is invalid; 3. patient that can understand the clinical trials and signed the informed consent. exclusion criteria: 1. patient that underwent other injection treatment within 6 weeks 2. some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue) 3. patient that enrolled other clinical trials within 3 months 4. history of drug/alcohol addiction, habitual smoker

Keywords: adipose-drived mesenchymal stem cells rotator cuff injury lateral epicondylitis randomized controlled trials
treatment seeking for social anxiety

Conditions: Social Anxiety

Summary: this study developed and then compared via randomized trial two brief online interventions targeting increasing treatment-seeking behavior in social anxiety.


Eligibility criteria:
inclusion criteria: * high social anxiety (score \>30 on social phobia inventory (spin) connor et al., 2000) * fluent in english * amazon mechanical turk hit approval rate \> 95% * amazon mechanical turk account listed as us resident exclusion criteria: * already enrolled in target treatments (i.e. cbt for social anxiety, using social anxiety self-help book, or participating in online treatment for social anxiety) * indicating that they would "never consider" treatment for social anxiety
lenvatinib plus sirt vs lenvatinib in tace-refractory hcc

Conditions: Hepatocellular Carcinoma Non-resectable

Summary: this study is conducted to evaluate the efficacy and safety of lenvatinib plus sirt (len+sirt) compared with lenvatinib (len) alone for patients with hepatocellular carcinoma (hcc) refractory to transarterial chemoembolization (tace).

this is a prospective, non-randomized controlled trial to evaluate the efficacy and safety of len+sirt versus len alone for patients with tace-refractory hcc. 78 patients (39 in each arm) with tace-refractory hcc will be enrolled in this study. the patients will receive either len+sirt or len. lenvatinib (body weight ≥ 60 kg, 12mg p.o. qd; body weight \< 60 kg, 8mg p.o. qd) will be administered to the patients and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. for patients in the len+sirt arm, lenvatinib will be started at 3-7 days after sirt. the primary end point of this study is objective response rate (orr). the secondary endpoints are disease control rate (dcr), progression-free survival (pfs), time to response (ttr), duration of response (dor), overall survival (os), and adverse events (aes).

Eligibility criteria:
inclusion criteria: * pathologically confirmed or clinically diagnosed hcc * diagnosis of hcc with tace refractoriness according to the criteria proposed by japan society of hepatology (2021) * patients who have tumor recurrence after surgical resection or ablation are allowed to be included * at least one measurable intrahepatic target lesion * child-pugh class a/b * eastern cooperative oncology group (ecog) performance status of 0 or 1 * tumor extent \<70% liver occupation * candidates for sirt must be confirmed suitable for sirt after evaluation (including spect/ct evaluation after arterial perfusion with 99tc-maa) * adequate organ and hematologic function with platelet count ≥50×10\^9/l, leukocyte \>3.0×10\^9/l, neutrophil count ≥1.5×10\^9/l, haemoglobin ≥85 g/l, alt and ast≤5×uln, albumin ≥28 g/l, total bilirubin ≤3× uln, creatinine≤1.5×uln, and prolongation of prothrombin time ≤4 seconds * life expectancy of at least 3 months exclusion criteria: * extrahepatic metastasis * tumor thrombus involving main portal vein or both the first left and right branches of portal vein * vena cava invasion * patients who received prior hepatic arterial infusion chemotherapy (haic), radiotherapy, or systemic therapy, for hcc * history of organ and cell transplantation * history of esophageal or gastric variceal bleeding * history of hepatic encephalopathy * history of other malignancies * human immunodeficiency virus infection

Keywords: hepatocellular carcinoma lenvatinib yttrium-90